Imperfect Pharmacy
B Pharmacy
Notes
6th Semester
PHARMACEUTICAL QUALITY ASSURANCE
Unit 1Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation: Principles and procedures
Unit 2
Organization and personnel: Personnel responsibilities, training, hygiene and personal
records. Premises: Design, construction and plant layout, maintenance, sanitation,
environmental control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
maintenance, purchase specifications and maintenance of stores for raw materials.
Unit 3
Quality Control: Quality control test for containers, rubber closures and secondary packing material
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Unit 4
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling
and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master
Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.
Unit 5
Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management.